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How to Be Prepared for Shifting Regulations on Combination Products
Program Code:
320
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Currently, Dr. Tunstall provides strategic insight into the development and evaluation of pharmaceuticals, medical devices, and human tissue products. She has also held a variety of positions in industry, and served as the Director of a clinical research site.
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PRESENTER
(S):
Ann Tunstall, Managing Consultant, SciLucent LLC
Mary Mease, Quintiles, Inc
Ajay is a Senior Consultant with WCI Consulting. He has 11 years of industry and consulting experience in supply chain, quality and compliance and drug safety across 5 continents. He holds a BE (Chemical) and MS (Biomedical) degree, both from the University of New South Wales, Sydney, Australia.
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Description
Regulations for combination products have remained in flux in recent times, which has affected the approach and execution of safety processes. This session will examine what re-tooling is required by companies in light of new regulations.
Learning Objectives:
Discuss clear ideas on how to remodel industry strategy and tactics away from a core competency
Discuss updated regulations and the potential need for reclassification of combination products.